english.prescrire.org > Positions > Transparency > Transparency and pharmacovigilance

Theme: Transparency

Transparency means full disclosure of the interests — and conflicts of interest — that come into play at all levels of the healthcare system. Prescrire consistently calls for – and practices – full transparency.

Transparency and pharmacovigilance

If we are serious about improving pharmacovigilance, in the interest of public health, we must minimise the role of pharmaceutical companies, ensure public funding and above all guarantee true transparency.

Under the current European system of pharmacovigilance, the expansion of bureaucratic procedures and safeguards — which is the result of the ever earlier and ever riskier granting of marketing authorisations — diffuses responsibility, slows down decision-making and keeps the public in the dark.

A reform measure has been announced, but it seems to be led mainly by pharmaceutical companies, rather than the authorities responsible for protecting public health.

When, within the framework of the International Conference on Harmonisation (ICH), drug companies and regulatory agencies adopt plans for "Development Safety Update Reports" (at the pre-marketing authorisation stage), they describe them as a tool for companies to present the adverse effects profiles of their medicines to agencies (1). When "risk management plans" become more prevalent, in Europe and elsewhere, they seem to be designed by companies and accepted by agencies, and they threaten to slow down the decision-making process.

When the new commissioner of the US Food and Drug Administration promises to reinforce pharmacovigilance, funding is based on increasing the fees paid by pharmaceutical companies.

When the WHO Collaborating Centre for International Drug Monitoring observed that agencies have difficulty interpreting all the data submitted by pharmaceutical companies, it actually suggested subcontracting the analysis to the companies themselves, in a "climate of confidence" (3), which the European Federation of Phamaceutical Industries and Associations views as a "partnership" (4). And so on.

If we are serious about improving pharmacovigilance, in the interest of public health, we must minimise the role of pharmaceutical companies, ensure public funding and above all guarantee true transparency.

©Prescrire 2007

Source: "Vigilance" Rev Prescrire 2007; 27 (282): 244.

References:
1- International Conference on Harmonisation Final concept Paper “E2D : Development Safety Update Report” 20 September 2006 : 4 pages.
2- Badey F “FDA. Enfin un patron… moins politique” Pharmaceutiques, Feburary 2007 : 36-37.
3- Edwards R and coll. “Are PSURs worthwhile ?” Uppsala Report January 2007 : 12-13.
4- European Commission “Assessment of the Community System of Pharmacovigilance”. Website http://www.ec-europa.eu/entreprise accessed on 27 February 2007.
More information:
[Uppsala Declaration,
International working group
on transparency and accountability
in drug regulation, 1996
Pdf, 29 Ko, free
 
Berlin Declaration on
Pharmacovigilance
ISDB EU 2005
Pdf, 222 Ko, free
 
The Erice Declaration on
communications in
pharmacovigilance
ISDB 1997
Pdf, 111 Ko, free